GliomaABCDNCT02652897

Hemostasis Alterations in Neurosurgical Patients

An observational study of Glioma and Coagulopathy, run by Santiago R. Leal-Noval at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

Prospective, observational study aimed to investigate the specific hemostatic alterations in patients undergoing glial tumor resection. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glioma, Coagulopathy, Acquired Platelet Function Disorder
What is being tested?: Exposure to glioma resection surgery and Exposure to colon resection surgery
Type of treatment: Surgery or procedure
How many people: 120 participants
Where: 1 siteSpain
Study dates: May 2016to Mar 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Consecutive patients undergoing elective glioma (study group) and colon (control group) surgeries.

Who may be able to join

Patients undergoing elective surgeries: glioma or colon cancer resections.

Who cannot join

Severe bleeding leading to patient's' death.
Incomplete tumor resection.
Peri operative complications leading to severe bleeding or prolonged ICU or hospital stay.
Peri operative blood components transfusion.
Peri operative transfusion of concentrate coagulation factors.
Intake of anti coagulant and / or antiaggregant drugs 7 days before surgery.
History of coagulopathy.
Inform consent denied for patients or relatives.

Trial locations and contacts

1 site in 1 country.

Santiago R. Leal-Noval, MD Ph.D contact

0034955012528 ext. 312528

srlealnoval@gmail.com

Spain1 site, 1 recruiting

Santiago R. Leal-Noval
Seville, 41013
Santiago R Leal-Noval, MD, 0034654864083 ext. 312528, srlealnoval@gmail.com
Recruiting

Other trials in Spain

About this study

Official title: Prospective Study on Hemostasis Alterations in Patients Undergoing Neuro Surgical Glioma Resection Acronym: (ABCD Study: Acute Brain Coagulopathy Development Study)

Prospective, observational study aimed to investigate the specific hemostatic alterations in patients undergoing glial tumor resection.

Read the detailed description

Brain parenchyma express tissue factor and other coagulation factors in high concentrations. In addition, neuro critical patients (NCP) may present platelet dysfunction, hyperfibrinolysis, hypo coagulation and / or hyper coagulation status, early after the injury. It is not known whether these alterations of hemostasis are due to a specific brain response to aggression, or they are included into a systemic response. This prospective, observational study is aimed to investigate the coagulation disorders specifically associated with cerebral aggression.

This is a prospective, cohort study including (calculated sample size) a study group of patients undergoing elective surgery (glial tumors) and other one undergoing colo rectal surgery. Alterations of the hemostasis will be evaluated by clotting tests, thromboelastometry and tests for platelet function. Samples will be drawn before and after surgical procedures. Multiple statistical comparisons intra and inter groups will be performed.

Conditions: Glioma, Coagulopathy, Acquired Platelet Function Disorder, Thromboelastometry, Surgery
Being tested: Exposure to glioma resection surgery, Exposure to colon resection surgery
Keywords: bleeding, clotting tests, neurosurgery, clotting time, maximum clot firmness, kinetics, lysis, primary hemostasis, platelet dysfunction, coagulation
Medical subject headings: Glioma, Hemostatic Disorders, Hemorrhage, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Exposure to glioma resection surgeryProcedure or surgery
The following blood samples will be drawn for hemostasis evaluation: 1. Conventional clotting tests, 2. Rotational thromboelastometry (ROTEM), including EXTEM and FIBTEM; 3. Platelet function as assessed by PFA-200 for; and 4. Platelet function as assessed by ara-tem, adp-tem and trap-tem. All the analyses will be performed before (within a period 24-h before surgery) and after (within of the following periods: 2 h, 24 h and 48 h after surgery).
Exposure to colon resection surgeryProcedure or surgery
The following blood samples will be drawn for hemostasis evaluation: 1. Conventional clotting tests, 2. Rotational thromboelastometry (ROTEM), including EXTEM and FIBTEM; 3. Platelet function as assessed by PFA-200 for; and 4. Platelet function as assessed by ara-tem, adp-tem and trap-tem. All the analyses will be performed before (within a period 24-h before surgery) and after (within of the following periods: 2 h, 24 h and 48 h after surgery).

Study groups in NCT02652897
Study group	Role	What they receive
Exposure to glioma resection surgery		Patients undergoing elective glioma resection Receives: Procedure: Exposure to glioma resection surgery
Exposure to colon resection surgery		Patients undergoing elective colon cancer resection Receives: Procedure: Exposure to colon resection surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of INR: International Normalized Ratio
Blood samples for assessing INR (clotting tests) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Measured: From 24-hour before surgery (baseline) at 48-hour after surgery
Change of aPTT: activated partial thromboplastin time (seconds).
Blood samples for assessing aPTT (clotting tests) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Measured: From 24-hour before surgery (baseline) at 48-hour after surgery
Change of CT / EXTEM: clotting time (seconds).
Blood samples for assessing CT / EXTEM (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Measured: From 24-hour before surgery (baseline) at 48-hour after surgery
Change of MCF / EXTEM: maximum clot firmness (mm)
Blood samples for assessing MCF / EXTEM (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Measured: From 24-hour before surgery (baseline) at 48-hour after surgery
Change of ML / EXTEM: Maximum lysis (%) percentage of clot which has actually lysed
Blood samples for assessing ML (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Measured: From 24-hour before surgery (baseline) at 48-hour after surgery
Change of col EPI (PFA-200): collage epinephrine bitartrate ( seconds)
Blood samples for assessing col EPI (measured by platelet function analyzer : PFA-200 test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Measured: From 24-hour before surgery (baseline) at 48-hour after surgery
Change of ara-tem / ROTEM values : platelet activation with arachidonic acid (ohm)
Blood samples for assessing A6 (amplitude at 6 minutes, ohm), MS (maximum slope, ohm/min), and AUC (area under curve, ohm* min), all of then measured by platelet function analyzer ROTEM will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Measured: From 24-hour before surgery (baseline) at 48-hour after surgery
Change of adp-tem / ROTEM values : platelet activation with adenosine diphosphate (ohm)
Blood samples for assessing A6 (amplitude at 6 minutes, ohm), MS (maximum slope, ohm/min), and AUC (area under curve, ohm* min), all of then measured by platelet function analyzer ROTEM will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Measured: From 24-hour before surgery (baseline) at 48-hour after surgery
Change of trap-tem / ROTEM values : platelet activation with thrombin activating peptide (ohm)
Blood samples for assessing A6 (amplitude at 6 minutes, ohm), MS (maximum slope, ohm/min), and AUC (area under curve, ohm* min), all of then measured by platelet function analyzer ROTEM will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Measured: From 24-hour before surgery (baseline) at 48-hour after surgery
Change of CT / FIBTEM: clotting time (seconds).
Blood samples for assessing CT / FIBTEM (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Measured: From 24-hour before surgery (baseline) at 48-hour after surgery
Change of MCF / FIBTEM: maximum clot firmness (mm)
Blood samples for assessing MCF / FIBTEM (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Measured: From 24-hour before surgery (baseline) at 48-hour after surgery
Change of coagulation factor XIII activity
Factor XIII chromogenic activity assay.
Measured: From 24-hour before surgery (baseline) at 48-hour after surgery

Secondary outcomes (2)

perioperative bleeding
Any bleeding occurring during this period.
Measured: from surgery to hospital discharge, an average of 2 weeks.
number of days
length of stay at ICU and hospital
Measured: from surgery to hospital discharge, an average of 2 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2016Mar 2019

First posted12 Jan 2016 (estimated)
Study startMay 2016
Primary completionFeb 2019 (estimated)
Study completionMar 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for GliomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02652897
Sponsor's protocol ID: FIS PI15 / 00512
Acronym: ABCD
Status last verified: Nov 2018
First submitted: 18 Dec 2015
Last updated: 27 Nov 2018
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

Leal-Noval SR, Cuenca DX, Diaz A, Fernandez-Pacheco J, Garcia-Garmendia JL, Casado M. Whole Blood Platelet Aggregation Assessed by ROTEM Platelet Equipment in Healthy Volunteers from Southern Europe: A Verification Study. J Appl Lab Med. 2023 May 4;8(3):551-558. doi: 10.1093/jalm/jfad008.
PubMed 36945200
Leal-Noval SR, Fernandez-Pacheco J, Casado-Mendez M, Cancela P, Narros JL, Arellano-Orden V, Dusseck R, Diaz-Martin A, Munoz-Gomez M. A prospective study on the correlation between thromboelastometry and standard laboratory tests - influence of type of surgery and perioperative sampling times. Scand J Clin Lab Invest. 2020 May;80(3):179-184. doi: 10.1080/00365513.2019.1704051. Epub 2019 Dec 17.
PubMed 31846350

Want to know more?

Santiago R. Leal-Noval, MD Ph.D

0034955012528 ext. 312528

srlealnoval@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glioma trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Study on Hemostasis Alterations in Patients Undergoing Neuro Surgical Glioma Resection Acronym: (ABCD Study: Acute Brain Coagulopathy Development Study)
ClinicalTrials.gov ID: NCT02652897
Acronym / sponsor ID: ABCD / FIS PI15 / 00512
Conditions: Glioma, Coagulopathy, Acquired Platelet Function Disorder, Thromboelastometry, Surgery
Keywords: bleeding, clotting tests, neurosurgery, clotting time, maximum clot firmness, kinetics, lysis, primary hemostasis
Study type: Observational
Recruitment status: Unknown status
Enrolment: 120 participants (estimated)
Lead sponsor: Santiago R. Leal-NovalUniversity, hospital or other
Collaborators: Instituto de Salud Carlos III
Study start: May 2016
Primary completion: Feb 2019 (estimated)
Study completion: Mar 2019 (estimated)
First posted: 12 Jan 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Prospective, observational study aimed to investigate the specific hemostatic alterations in patients undergoing glial tumor resection.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Exposure to glioma resection surgery	–	Procedure: Exposure to glioma resection surgeryPatients undergoing elective glioma resection
Exposure to colon resection surgery	–	Procedure: Exposure to colon resection surgeryPatients undergoing elective colon cancer resection

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Consecutive patients undergoing elective glioma (study group) and colon (control group) surgeries.

Key inclusion criteria (1 listed)

Patients undergoing elective surgeries: glioma or colon cancer resections.

Key exclusion criteria (8 listed)

Severe bleeding leading to patient's' death.
Incomplete tumor resection.
Peri operative complications leading to severe bleeding or prolonged ICU or hospital stay.
Peri operative blood components transfusion.
Peri operative transfusion of concentrate coagulation factors.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Exposure to glioma resection surgeryThe following blood samples will be drawn for hemostasis evaluation: 1. Conventional clotting tests, 2. Rotational thromboelastometry (ROTEM), including EXTEM and FIBTEM; 3. Platelet function as assessed by PFA-200 for; and 4. Platelet function as assessed by ara-tem, adp-tem and trap-tem. All the analyses will be performed before (within a period 24-h before surgery) and after (within of the following periods: 2 h, 24 h and 48 h after surgery).	Procedure or surgery	Exposure to glioma resection surgery
Exposure to colon resection surgeryThe following blood samples will be drawn for hemostasis evaluation: 1. Conventional clotting tests, 2. Rotational thromboelastometry (ROTEM), including EXTEM and FIBTEM; 3. Platelet function as assessed by PFA-200 for; and 4. Platelet function as assessed by ara-tem, adp-tem and trap-tem. All the analyses will be performed before (within a period 24-h before surgery) and after (within of the following periods: 2 h, 24 h and 48 h after surgery).	Procedure or surgery	Exposure to colon resection surgery

Primary outcome

Change of INR: International Normalized Ratio
Time frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing INR (clotting tests) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of aPTT: activated partial thromboplastin time (seconds).
Time frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing aPTT (clotting tests) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of CT / EXTEM: clotting time (seconds).
Time frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing CT / EXTEM (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of MCF / EXTEM: maximum clot firmness (mm)
Time frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing MCF / EXTEM (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of ML / EXTEM: Maximum lysis (%) percentage of clot which has actually lysed
Time frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing ML (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of col EPI (PFA-200): collage epinephrine bitartrate ( seconds)
Time frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing col EPI (measured by platelet function analyzer : PFA-200 test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of ara-tem / ROTEM values : platelet activation with arachidonic acid (ohm)
Time frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing A6 (amplitude at 6 minutes, ohm), MS (maximum slope, ohm/min), and AUC (area under curve, ohm* min), all of then measured by platelet function analyzer ROTEM will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of adp-tem / ROTEM values : platelet activation with adenosine diphosphate (ohm)
Time frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing A6 (amplitude at 6 minutes, ohm), MS (maximum slope, ohm/min), and AUC (area under curve, ohm* min), all of then measured by platelet function analyzer ROTEM will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of trap-tem / ROTEM values : platelet activation with thrombin activating peptide (ohm)
Time frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing A6 (amplitude at 6 minutes, ohm), MS (maximum slope, ohm/min), and AUC (area under curve, ohm* min), all of then measured by platelet function analyzer ROTEM will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of CT / FIBTEM: clotting time (seconds).
Time frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing CT / FIBTEM (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of MCF / FIBTEM: maximum clot firmness (mm)
Time frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing MCF / FIBTEM (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of coagulation factor XIII activity
Time frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Factor XIII chromogenic activity assay.

2 secondary outcomes

perioperative bleeding
Time frame: from surgery to hospital discharge, an average of 2 weeks.
number of days
Time frame: from surgery to hospital discharge, an average of 2 weeks.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
Derived from this study: PubMed 36945200Leal-Noval SR, Cuenca DX, Diaz A, Fernandez-Pacheco J, Garcia-Garmendia JL, Casado M. Whole Blood Platelet Aggregation Assessed by ROTEM Platelet Equipment in Healthy Volunteers from Southern Europe: A Verification Study. J Appl Lab Med. 2023 May 4;8(3):551-558. doi: 10.1093/jalm/jfad008.
Derived from this study: PubMed 31846350Leal-Noval SR, Fernandez-Pacheco J, Casado-Mendez M, Cancela P, Narros JL, Arellano-Orden V, Dusseck R, Diaz-Martin A, Munoz-Gomez M. A prospective study on the correlation between thromboelastometry and standard laboratory tests - influence of type of surgery and perioperative sampling times. Scand J Clin Lab Invest. 2020 May;80(3):179-184. doi: 10.1080/00365513.2019.1704051. Epub 2019 Dec 17.
Individual participant dataSharing planned: No

Related trials for Glioma

Active, not recruitingPhase 1/2
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Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Santiago R. Leal-Noval, MD Ph.D contact

0034955012528 ext. 312528

srlealnoval@gmail.com

Santiago R. Leal-Noval, MD Ph.D principal investigator

University Hospital "Virgen del Rocío", Seville, Spain

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Glioma and Coagulopathy, run by Santiago R. Leal-Noval at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Santiago R. Leal-Noval, MD Ph.D (0034955012528 ext. 312528, srlealnoval@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of INR: International Normalized Ratio (time frame: From 24-hour before surgery (baseline) at 48-hour after surgery). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02652897, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.